Opioid UseNCT03352479
Safe Return and Disposal of Unused Opioids
A study testing Opioid Return in people with Opioid Use and Opioid Dependence, run by Baylor College of Medicine.
Trial summary
The opioid epidemic in the United States has become a clear health and safety concern for our children and families. Opioids given to our patients for the treatment of pain that go unused after the immediate post operative period pose a major hazard when left in the home unattended. Read more about this study
- Who is it for?
- Ages Up to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid Use, Opioid Dependence, Opioid Abuse, Unspecified
- What is being tested?
- Opioid Return
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2017to 30 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 64 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- All patients being prescribed opioids at discharge in the Clinical Care Center/Wallace Tower Surgical Center or at the Woodlands Campus who have undergone a surgical procedure.
Who cannot join
- Parental Refusal to participate Patients not being prescribed opioids for discharge Patients on chronic opioid therapy/chronic pain patients International patients returning abroad (these takeaway envelopes are only paid through the 50 US states, DC and Puerto Rico)
About this study
Official title: Keeping Your Children and Home Safe Through Return and Disposal of Unused Opioids
The opioid epidemic in the United States has become a clear health and safety concern for our children and families. Opioids given to our patients for the treatment of pain that go unused after the immediate post operative period pose a major hazard when left in the home unattended. Opioids can be accidentally ingested by small children or deliberately ingested by pre-teens and adolescents leading to major morbidity and or death. Additionally, studies have shown that many people addicted to opioids/narcotics have become so due to ingestion of medically prescribed drugs. Finally, there has been an increase number of home robberies specifically with the intent to steal prescription drugs. Removal of unused medication from the home is an important public safety concern to protect our patients, families and friends. The Sharps Co (R), offers a product called Takeaway Medication Recovery System. This product allows individuals to put unused opioids in a pre-paid envelope which is returned to the company through the postal system and properly incinerated. This provides safe disposal in accordance with the Environmental Protection Agency (EPA) to protect the water table from contamination by drugs disposed of my other means. This system through the Sharps Co would allow for de-identified tracking of returned drugs.
Read the detailed description
Participants identified by the PI and participating research staff/coordinators that will receive opioids following discharge will be approached. The participant information sheet will be provided to the parents/legal guardian and explained. The consenting study coordinator will review the potential risks of opioids as described in the information sheet. A brief demonstration of the TakeAway envelope will be provided. The participants will be instructed that there is absolutely no cost to them or their family and that the envelope is pre-paid and that all returned or unreturned contents are strictly confidential. A few brief demographic questions will be asked and are completely optional. The participant will be asked for an email and contacted 15 days and 30 days following the procedure. The email will strictly be a reminder to return all un-used medication using the provided envelope Or an optional response reporting nothing to return. If participants do not have an email or do not wish to be contacted, they may still enroll in the study. The entire peri-operative period will progress in the usual manner.
Each envelope has a serial number that will be recorded during enrollment - the company provides access to ascertain exactly how many pills are returned. This access is strictly provided to the PI. The company will have no patient information and therefore only the PI will be able to track the serial number to the patient. The PI and research staff will record the number of pills prescribed to the patient to allow the research team to calculate the percentage of pills returned.
- Conditions
- Opioid Use, Opioid Dependence, Opioid Abuse, Unspecified
- Being tested
- Opioid Return
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opioid ReturnOther
Calculate the percentage of prescribed to returned opioids
| Study group | Role | What they receive |
|---|---|---|
| Opioids Prescribed | Other | Each participant in the study will be given an envelope for return of unused opioids. The percentage of returned number of opioids will be calculated based on the number prescribed Receives: Other: Opioid Return |
What is being measured
The primary outcome is the main question the study is designed to answer.
% of prescribed unused opioids returned
Calculate the percentage of opioids that are prescribed that are safely returned by participants and their families
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2017
- Study start1 Dec 2017 (estimated)
- Primary completion30 Jun 2018 (estimated)
- Study completion30 Jul 2018 (estimated)
Why it stopped: this is an observational project and doesn't not meet any of the four criteria required for listing on clinical trials.gov
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Each participant will be given on envelope to return unused opioids
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Chandrakantan
- Responsible party
- Principal investigator, Adam Adler MD, MS, FAAP, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03352479
- Sponsor's protocol ID
- H42451
- Status last verified
- Mar 2020
- First submitted
- 21 Nov 2017
- Last updated
- 31 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Adler AC, Yamani AN, Sutton CD, Guffey DM, Chandrakantan A. Mail-Back Envelopes for Retrieval of Opioids After Pediatric Surgery. Pediatrics. 2020 Mar;145(3):e20192449. doi: 10.1542/peds.2019-2449. Epub 2020 Feb 12.
PubMed 32051219
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Keeping Your Children and Home Safe Through Return and Disposal of Unused Opioids
- ClinicalTrials.gov ID
- NCT03352479
- Acronym / sponsor ID
- H42451
- Conditions
- Opioid Use, Opioid Dependence, Opioid Abuse, Unspecified
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: this is an observational project and doesn't not meet any of the four criteria required for listing on clinical trials.gov
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- Chandrakantan
- Study start
- 1 Dec 2017 (estimated)
- Primary completion
- 30 Jun 2018 (estimated)
- Study completion
- 30 Jul 2018 (estimated)
- First posted
- 24 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The opioid epidemic in the United States has become a clear health and safety concern for our children and families. Opioids given to our patients for the treatment of pain that go unused after the immediate post operative period pose a major hazard when left in the home unattended. Opioids can be accidentally ingested by small children or deliberately ingested by pre-teens and adolescents leading to major morbidity and or death. Additionally, studies have shown that many people addicted to opioids/narcotics have become so due to ingestion of medically prescribed drugs. Finally, there has been an increase number of home robberies specifically with the intent to steal prescription drugs. Removal of unused medication from the home is an important public safety concern to protect our patients, families and friends. The Sharps Co (R), offers a product called Takeaway Medication Recovery System. This product allows individuals to put unused opioids in a pre-paid envelope which is returned to the company through the postal system and properly incinerated. This provides safe disposal in accordance with the Environmental Protection Agency (EPA) to protect the water table from contamination by drugs disposed of my other means. This system through the Sharps Co would allow for de-identified tracking of returned drugs.
Detailed description
Participants identified by the PI and participating research staff/coordinators that will receive opioids following discharge will be approached. The participant information sheet will be provided to the parents/legal guardian and explained. The consenting study coordinator will review the potential risks of opioids as described in the information sheet. A brief demonstration of the TakeAway envelope will be provided. The participants will be instructed that there is absolutely no cost to them or their family and that the envelope is pre-paid and that all returned or unreturned contents are strictly confidential. A few brief demographic questions will be asked and are completely optional. The participant will be asked for an email and contacted 15 days and 30 days following the procedure. The email will strictly be a reminder to return all un-used medication using the provided envelope Or an optional response reporting nothing to return. If participants do not have an email or do not wish to be contacted, they may still enroll in the study. The entire peri-operative period will progress in the usual manner.
Each envelope has a serial number that will be recorded during enrollment - the company provides access to ascertain exactly how many pills are returned. This access is strictly provided to the PI. The company will have no patient information and therefore only the PI will be able to track the serial number to the patient. The PI and research staff will record the number of pills prescribed to the patient to allow the research team to calculate the percentage of pills returned.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Each participant will be given on envelope to return unused opioids
| Arm | Type | Receives |
|---|---|---|
| Opioids Prescribed | Other | Other: Opioid ReturnEach participant in the study will be given an envelope for return of unused opioids. The percentage of returned number of opioids will be calculated based on the number prescribed |
Who may qualify
- Ages
- Up to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- All patients being prescribed opioids at discharge in the Clinical Care Center/Wallace Tower Surgical Center or at the Woodlands Campus who have undergone a surgical procedure.
Key exclusion criteria (1 listed)
- Parental Refusal to participate Patients not being prescribed opioids for discharge Patients on chronic opioid therapy/chronic pain patients International patients returning abroad (these takeaway envelopes are only paid through the 50 US states, DC and Puerto Rico)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Opioid ReturnCalculate the percentage of prescribed to returned opioids | Other | Opioids Prescribed |
Primary outcome
% of prescribed unused opioids returned
Time frame: six months
Calculate the percentage of opioids that are prescribed that are safely returned by participants and their families
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
- Derived from this study: PubMed 32051219Adler AC, Yamani AN, Sutton CD, Guffey DM, Chandrakantan A. Mail-Back Envelopes for Retrieval of Opioids After Pediatric Surgery. Pediatrics. 2020 Mar;145(3):e20192449. doi: 10.1542/peds.2019-2449. Epub 2020 Feb 12.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Opioid Return in people with Opioid Use and Opioid Dependence, run by Baylor College of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
% of prescribed unused opioids returned (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03352479, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2020.